Data / Medical devices / Germany / TOMTEC Imaging Systems GMBH

TOMTEC Imaging Systems GMBH: FDA-registered device maker in UNTERSCHLEISSHEIM Bavaria, Germany, 5 510(k) clearances

Name: TOMTEC Imaging Systems GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

TOMTEC Imaging Systems GMBH is registered with the FDA (registration 8043836) in UNTERSCHLEISSHEIM Bavaria, Germany. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 10, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8043836
FEI number: 1000185293
Address: Freisinger Strasse 9, UNTERSCHLEISSHEIM Bavaria, Germany, 85716
Owner or operator: Philips Medical Systems International BV (1217116)
Roles: Manufacturer, Specification developer
First device listed: December 19, 2017
Registered through: 2026
Brand names listed: Image-Arena 4.5, Echo-Com 4.5, Image-Com 4.5, Image-Arena and Image-Arena Applications, TOMTEC-ARENA, TomTec-Arena, Ultrasound Workspace

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Manufacturer, Specification developer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer, Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 10, 2025	K241659	Ultrasound Workspace (UWS 6.0)	QIH	Substantially Equivalent	Philips Ultrasound, LLC	accessdata.fda.gov
January 6, 2022	K213544	TOMTEC-ARENA	QIH	Substantially Equivalent	Tomtec Imaging Systems GmbH	accessdata.fda.gov
August 14, 2020	K201632	TOMTEC-ARENA	LLZ	Substantially Equivalent	Tomtec Imaging Systems GmbH	accessdata.fda.gov
February 13, 2015	K150122	TOMTEC-ARENA TTA2	LLZ	Substantially Equivalent	Tomtec Imaging Systems GmbH	accessdata.fda.gov
April 8, 2011	K110667	IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS	LLZ	Substantially Equivalent	Tomtec Imaging Systems GmbH	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 23, 2019	85392	Class II	Ongoing	TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 release prior to UDI requireme	The firm discovered a software issue associated with the Image-Com module/clinical application package (CAP) interface for 3D application in the ARENA software, where measurements from one study might be stored to another study.	accessdata.fda.gov

Compare with other makers

Updated February 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.